Is the risk really able to be calculated? From what I know there are no cases of PML in mono testing only. So if 3,000 people were in the study, how many were on Ty only? And if the sample were statistically valid and no one contracted PML, would the risk be zero? Interesting to look at it this way?
Yes, it was during a discussion about the risk-map.
Actually the lead-in was when L.E. was asked if Elan had a risk-map for biib.and then discussion ensued.
I dont recall if mono or combo was specified.(a lot of comments flying back and forth and difficult to recall all)
Perhaps one of the others can clarify.
On a related issue, the risk that they refer to is the risk of PML. To read much of the commentary you would think they were talking about the risk of death - that pisses me off.
Not a stats person myself, but I'd wager that risk (of death) is probably no worse than the risk of getting hit by a bus on the way to the clinic!
Just thinking out loud but I'd assume he meant the risk in mono. The risk in combo is obviously so high that both regulators arent going to accept it - hence only MONOTHERAPY approval from FDA and EMEA.